title: Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer.
abstract: OBJECTIVE
  To determine if escalated radiation dose using hypofractionation significantly reduces biochemical and/or clinical disease failure (BCDF) in men treated primarily for prostate cancer.
  
  
  METHODS
  Between June 2002 and May 2006, men with favorable- to high-risk prostate cancer were randomly allocated to receive 76 Gy in 38 fractions at 2.0 Gy per fraction (conventional fractionation intensity-modulated radiation therapy [CIMRT]) versus 70.2 Gy in 26 fractions at 2.7 Gy per fraction (hypofractionated IMRT [HIMRT]); the latter was estimated to be equivalent to 84.4 Gy in 2.0 Gy fractions. High-risk patients received long-term androgen deprivation therapy (ADT), and some intermediate-risk patients received short-term ADT. The primary end point was the cumulative incidence of BCDF. Secondarily, toxicity was assessed.
  
  
  RESULTS
  There were 303 assessable patients with a median follow-up of 68.4 months. No significant differences were seen between the treatment arms in terms of the distribution of patients by clinicopathologic or treatment-related (ADT use and length) factors. The 5-year rates of BCDF were 21.4% (95% CI, 14.8% to 28.7%) for CIMRT and 23.3% (95% CI, 16.4% to 31.0%) for HIMRT (P = .745). There were no statistically significant differences in late toxicity between the arms; however, in subgroup analysis, patients with compromised urinary function before enrollment had significantly worse urinary function after HIMRT.
  
  
  CONCLUSIONS
  The hypofractionation regimen did not result in a significant reduction in BCDF; however, it is delivered in 2.5 fewer weeks. Men with compromised urinary function before treatment may not be ideal candidates for this approach.
authors.affiliation: Alan Pollack, Gail Walker, and Radka Stoyanova, University of Miami Miller School of Medicine, Miami, FL; Eric M. Horwitz, Robert Price, Richard E. Greenberg, Robert G. Uzzo, Charlie Ma, and Mark K. Buyyounouski, Fox Chase Cancer Center, Philadelphia, PA; Steven Feigenberg, University of Maryland, Baltimore, MD; Andre A. Konski, Wayne State University Medical Center; and Benjamin Movsas, Henry Ford Hospital, Detroit, MI.
authors.forename: Alan
authors.initials: A
authors.lastname: Pollack
authors.forename: Gail
authors.initials: G
authors.lastname: Walker
authors.forename: Eric M
authors.initials: EM
authors.lastname: Horwitz
authors.forename: Robert
authors.initials: R
authors.lastname: Price
authors.forename: Steven
authors.initials: S
authors.lastname: Feigenberg
authors.forename: Andre A
authors.initials: AA
authors.lastname: Konski
authors.forename: Radka
authors.initials: R
authors.lastname: Stoyanova
authors.forename: Benjamin
authors.initials: B
authors.lastname: Movsas
authors.forename: Richard E
authors.initials: RE
authors.lastname: Greenberg
authors.forename: Robert G
authors.initials: RG
authors.lastname: Uzzo
authors.forename: Charlie
authors.initials: C
authors.lastname: Ma
authors.forename: Mark K
authors.initials: MK
authors.lastname: Buyyounouski
mesh_terms: D000368:Aged; D019583:Dose Fractionation, Radiation; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000517:prevention & control; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D017430:Prostate-Specific Antigen